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BXCL501 Film · 1 trial · 6 indications
The aim of the study is to assess the agreement/correlations among different measures so the comment is correct that different units of measure are being assessed. The informant-completed questionnaire (modified clinical global impression of severity for informants (mCGI-S-INF) and the clinical-rater completed questionnaire, Positive and Negative Syndrome Scale - Excited Component (PEC) are the primary outcomes being assessed. The mCGI-S-INF is a single item with a 0 to 3 point scale with higher values indicating more severe agitation. The PEC is a five item questionnaire with 7-point response options, overall scores range from 5 to 35 with higher scores indicating more severe agitation.
Assess content validity of the Modified Clinical Global Impression of Severity for Informants (mCGI-S-INF) and informant training materials. The scale being utilized is mCGI-S-INF. There is no score as it is a qualitative assessment and it is being validated to measure patient informant reported outcomes against patient reported outcomes (mCGI-S-PAT) and physician reported outcomes using the Positive and Negative Syndrome Scale - Excited Component (PEC) scale where the highest score indicates the maximum agitation that could be experienced.
| Arm | Type | Description |
|---|---|---|
| BXCL501 Sublingual film | EXPERIMENTAL | Experimental: 120 mcg of BXCL501 Sublingual film containing 120 Micrograms Dexmedetomidine |
| Name | Type | Description |
|---|---|---|
| BXCL501 Sublingual Film | DRUG | Single dose BXCL501 120 mcg |
Inclusion Criteria for Participant: 1. Male and female patients 18 to 75 years old, inclusive. 2. Patients who can read, understand, and provide written informed consent. 3. Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, v5, Text Revision (DSM-5-TR) criteria for a prim...
BXCL501 Film is an investigational small molecule being studied for the treatment of Bipolar I Disorder. It is a sublingual film formulation developed by BioXcel Therapeutics, Inc. for the management of acute psychomotor agitation associated with psychiatric conditions, including Bipolar I Disorder.
BXCL501 Film is a small molecule that acts on the central nervous system to address acute psychomotor agitation. The specific molecular target is not disclosed in the available information, but the drug is designed to provide rapid calming effects in patients with psychiatric disorders.
BXCL501 Film is developed by BioXcel Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker BTAI. The company focuses on developing innovative therapies for neuroscience and immuno-oncology indications.
BXCL501 Film is currently in Phase 2 clinical development. It has received Breakthrough Therapy and Fast Track designations from the FDA, indicating its potential to address serious conditions. The drug is investigational and not yet approved for commercial use.
BXCL501 Film has one completed Phase 2 clinical trial, NCT07116694, which assessed acute psychomotor agitation measures in patients with schizophrenia and bipolar disorder. The trial enrolled 33 participants in the United States and included patients with Bipolar I Disorder, Bipolar II Disorder, and other related conditions.
BXCL501 Film is a specific formulation of the drug BXCL501, which is a sublingual film version. The film formulation is designed for rapid absorption and onset of action. The drug is being developed by BioXcel Therapeutics for acute agitation in psychiatric disorders.